PLIMATH

PLIMATH

A Phase II Study to Determine Pembrolizumab as Frontline Treatment of Patients With Hodgkin Lymphoma (PLIMATH)

Disease:

Hodgkin Lymphoma

Summary:

Hodgkin lymphoma is an aggressive form of lymphoma, which is a cancer of the immune system. Symptoms include enlarged lymph nodes, fevers, drenching sweats (particularly at night), weight loss and itching.

There are very effective chemotherapy options available to treat Hodgkin lymphoma, but in some people these may not be suitable or safe to use (eg. Older people, or people with other health conditions).

The immune system is the body’s first line of defence against cancer. There are novel non chemotherapy drugs being developed for treating Hodgkin lymphoma, which target different parts of the immune system. This type of treatment is known as immunotherapy. One group of immunotherapy drugs being developed are PD-1 inhibitors. The PD-1 pathway is part of the immune system, and is involved in the interactions of T cells (one type of white blood cell) with cancer cells. PD-1 inhibitors can increase the activity of T cells to detect and kill cancer cells.

This trial is for people who have Hodgkin lymphoma which has not yet been treated, and for whom the standard chemotherapy regimen is not suitable. The aim of the study is to evaluate the safety and effectiveness of a PD-1 inhibitor called Pembrolizumab.

Eligibility:

Include, but not limited to, the following:

Inclusion Criteria:
1. Have a diagnosis of Hodgkin lymphoma stage III or IV disease (or stage II disease that cannot be irradiated without unacceptable toxicity)
2. The patient must meet one of the following criteria:
a. Age ≥65
b. Age >18 and considered ineligible for standard therapy (front-line ABVD combination chemotherapy) due to medical reasons
3. Have measurable disease based on the Lugano classification
4. Be willing to provide tissue from a "newly-obtained" core or excisional biopsy of a tumour lesion
5. Have a performance status of 0-2 on the ECOG Performance Scale
6. Demonstrate adequate organ function as defined in Protocol
7. Female patient of childbearing potential should have a negative urine/serum pregnancy test and be willing to use an adequate method of contraception as outlined in Protocol
8. Male patients of childbearing potential must agree to use an adequate method of contraception as outlined in Protocol

Exclusion Criteria:
1. Is currently receiving study therapy or has received study therapy within 4 weeks of registration
2. Is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days of registration. NOTE: See Protocol for further information
3. Has a known history of active TB (Bacillus Tuberculosis)
4. Hypersensitivity to pembrolizumab or any of its excipients
5. Has had a prior anti-cancer monoclonal antibody (MoAb) within 4 weeks prior to registration
6. Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks of registration
7. Subject has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent
8. Subject has a history of other active malignancies other than HL within the past 2 years prior to study entry *NOTE: See protocol for exemptions
9. Has a history of non-infectious pneumonitis that required steroids or has current pneumonitis.
10. Has an active infection requiring systemic therapy more than oral antibiotics.
11. Has a history or current condition, therapy, or laboratory abnormality that might confound the results of the trial or interfere with the patient's participation for the full duration of the study
12. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
13. Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
14. Has received therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent in the preceding 12 months.
15. Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
16. Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected).
17. Has received a live vaccine within 30 days of registration.
Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.
18. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis *NOTE: See protocol for more information

See https://clinicaltrials.gov/ct2/show/NCT03331731 for further protocol eligibility information

Contact person:

Alex Zagwocki, Clinical trials Coordinator, Linear Clinical Research
Email azagwocki@linear.org.au
Phone


Email
Phone

Principal Investigator:

Dr Chan Cheah

Sponsor:

Peter Maccullum Centre, Melbourne

Phase:

II

Protocol Number:

LO180502

Trial Registration Number:

NCT03331731

Clinical Trials.gov

ANZ Clinical Trial Registry